Specialist, Downstream Manufacturing (Downstream Bioprocess Associate)
My client is seeking a Specialist, Downstream Manufacturing to join their Manufacturing Operations group. This role reports to the Senior Manager, Downstream Manufacturing Shift Lead and will support both ongoing manufacturing operations and commissioning/qualification activities for process equipment. Please note this is a 24/7 shift role.
Key Duties and Responsibilities:
* Collaborate with the manufacturing operations group, project design team, CQV team, and Automation/CSV representatives to implement project design and validation for the facility.
* Create operating procedures and other relevant documentation for large scale manufacturing.
* Execute commercial manufacturing processes according to established work instructions.
* Adhere to Good Manufacturing Practices and Standard Operating Procedures.
* Participate in investigations and process optimisations using scientific, engineering, and lean principles.
* Operate production equipment within the assigned functional area.
* Use process automation systems (Delta V, Syncade Interactions, OSI/Pi Historian) and supporting business systems (SAP, Trackwise, Maximo).
* Review batch and exception reports in conjunction with Quality representatives and provide input to investigations and QA audit activities.
* Support a culture of continuous improvement and operational excellence through ownership of process, equipment, and safe working practices.
Qualifications, Knowledge and Skills Required:
* Minimum Level 6 qualification in Engineering or Science, or relevant experience in a regulated industry (cGMP, ISO, or cleanroom strongly preferred).
* 1 to 3+ years of experience in a large scale biopharmaceutical manufacturing facility preferred.
* Experience with Delta V and MES is an advantage.
* Ability to work independently and as part of a team.
* Strong problem solving skills with the ability to meet scheduled timelines.
* Excellent communication skills and proven ability to collaborate in cross functional environments.
Additional Information:
This role requires shift work to support 24/7 operations.
The Next Step for you:
Should this position be of interest to you please submit your CV to
Barry O'Mahony
from Next Generation Recruitment using the apply button.
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